Status:
ACTIVE_NOT_RECRUITING
Understanding Dose Related Effects of Strawberry
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Conditions:
Pre-diabetes
Insulin Sensitivity
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
The proposed research is designed to extend previous research findings building on the knowledge of strawberries as fruits that support a healthy immune and vascular system. The proposed research leve...
Detailed Description
Investigators are proposing to leverage ongoing research funded by USDA to study in greater depth the effect of strawberry intake on chronic low grade inflammation and its relation to endothelial func...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Men or women 20-60 years of age
- High sensitivity C-Reactive Protein (hs-CRP), a global marker of inflammation, \>1.0 and ≤10 ng/L
- BMI ≥ 25 kg/m2
- Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 1 years). Occasional smoker may be allowed at investigator discretion
- Judged to be in good health on the basis of the medical history ie., no clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, dietary supplements, etc.
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, records of food diary and study visit schedule)
- Able to maintain usual physical activity pattern
- Able to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during study visit
- Exclusion Criteria:
- Men and women who smoke regularly
- Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
- Men and women who have blood pressure \>160 mmHg (systolic)/100 mmHg (diastolic) at screening visit
- Men and women who have fasting blood glucose concentration \>125 mg/dL at screening visit
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results
- Men and women with cancer other than non-melanoma skin cancer in previous 5 years
- Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are lactating
- Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30-day washout); e.g., fish oil, probiotics, etc...
- Men and women who has participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
- Major trauma or a surgical event within 2 months or longer depending on trauma or event and after consultation with PI.
- Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator.
- Has a known intolerance or sensitivity to any ingredients in the study products
- Has used antibiotics within the previous 2 months
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
- Substance (alcohol or drug) abuse within the last 2 years
- Excessive coffee and tea consumers (\> 4 cups/d)
- Donated blood within last 3 months
- Men and women who do excessive exercise regularly or are an athlete
- Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
- Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
- Unusual working hours i.e., working overnight (e.g. 3rd shift)
Exclusion
Key Trial Info
Start Date :
August 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 28 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06173765
Start Date
August 31 2022
End Date
January 28 2026
Last Update
July 11 2025
Active Locations (1)
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1
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616